Toric lens with decreased sensitivity to cylinder power and rotation and method of using the same

ABSTRACT

A method, system and apparatus for vision correction are disclosed. The method, system and apparatus include a toric intraocular element for correcting astigmatism and having a cylinder power, and a depth of focus extender coupled to the toric intraocular element, the depth of focus extender extending a depth of focus. The extended depth of focus may reduce sensitivity of the toric intraocular element to at least one of rotation and selected cylinder power.

CROSS-REFERENCE OF RELATED APPLICATIONS

This application claims priority to and is a divisional application ofU.S. application Ser. No. 12/832,816 filed on Jul. 8, 2010, which claimspriority to and is a continuation-in-part application of both U.S.application Ser. No. 12/120,201, filed on May 13, 2008 and U.S.application Ser. No. 12/197,249, filed on Aug. 23, 2008, both of whichclaim priority to U.S. Provisional Application No. 60/968,250, filed onAug. 27, 2007. The aforementioned applications are hereby incorporatedby reference as if set forth herein in their entirety.

FIELD OF THE INVENTION

The present invention is related to vision correction, and, moreparticularly, to vision correction using a toric lens with decreasedsensitivity to cylinder power and rotation.

BACKGROUND OF THE INVENTION

Surgery on the human eye has become commonplace in recent years. Manypatients pursue eye surgery as an elective procedure, such as to avoidthe use of contacts or glasses, and other patients may find it necessaryto pursue surgery to correct an adverse condition in the eye. Suchadverse conditions may include, for example, cataracts or presbyopia, aswell as other conditions known to those skilled in the art that maynegatively affect elements of the eye.

The anatomy and physiology of the human eye is well understood.Generally speaking, the structure of the human eye includes an outerportion, also referred to as a layer, formed of two parts, namely thecornea and the sclera. The middle layer of the eye includes the iris,the choroid, and the ciliary body. The inner layer of the eye includesthe retina. The eye also includes, physically associated with the middlelayer, a crystalline lens that is contained within an elastic capsule,referred to herein as the lens capsule, or capsular bag.

Image formation in the eye occurs by entry of image-forming light to theeye through the cornea, and refraction by the cornea and the crystallinelens to focus the image-forming light on the retina. The retina providesthe light sensitive tissue of the eye.

Functionally, the cornea has a greater, and generally constant, opticalpower in comparison to the crystalline lens. The power of thecrystalline lens, while smaller than that of the cornea, may be changedwhen the eye needs to focus at different distances. This change, or“accommodation,” is achieved by changing the shape of the crystallinelens. Accommodation, as used herein, includes the making of a change inthe focus of the eye for different distances. For example, in order tochange the shape of the crystalline lens for accommodation, the ciliarymuscles may contract to cause ligaments that support the crystallinelens to relax, thereby allowing the crystalline lens to become morerounded.

The iris operates to change the aperture size of the eye. Morespecifically, the diameter of the incoming light beam is controlled bythe iris, which provides the aperture of the eye, and the ciliarymuscles may contract, as referenced above, to provide accommodation inconjunction with any needed change in the size of the aperture providedby the iris. The opening, or aperture, in the iris is called the pupil.

Correction of defects or degradation in the aspects of the eye may occursurgically, as mentioned above. In a simple example, it is common towear glasses or contact lenses to improve vision by correcting myopic(near-sighted), hyperopic (far-sighted) and astigmatic eyesight. Ratherthan relying on glasses or contacts, elective laser refractive surgery,or other eye surgery, may serve to improve the refractive state of theeye, including improvement to astigmatism, and may thereby decrease oreliminate dependency on glasses or contact lenses. Such surgeries mayinclude various methods of surgical remodeling of the cornea, orcataract surgery, for example. Surgery may also serve to implant anintraocular lens (IOL), either in addition to the crystalline lens,which addition is referred to as a phakic IOL, or upon removal of thecrystalline lens, which replacement is referred to as a pseudophakicIOL.

In particular, an IOL may be a lens implanted in the eye, such as toreplace the existing crystalline lens when the crystalline lens has beenclouded over by a cataract, for example, or as a refractive element tochange the eye's optical power. An IOL is one type of corrective lensthat may change the focus of the elements of the eye. This change infocus provided by a corrective lens is herein referred to as defocus.

An IOL may consist of a small plastic lens with plastic side struts,called haptics, to hold the lens in place within the capsular bag. AnIOL may be made of a relatively inflexible material, such as polymethylmethacrylate (PMMA), for example, or of a flexible material, such assilicone, acrylic, hydrogels, and the like. An IOL may be a fixedmonofocal lens matched to distance vision, for example. An IOL may alsobe multifocal to provide the recipient with multiple-focused vision atfar and reading distances, for example. An IOL may be used to providethe patient with limited visual accommodation, for example.

An IOL may be either spheric or toric. Spheric IOLs are used forcorrection of a myriad of vision problems, while toric IOLs aretypically used for astigmatic eye correction. When using a toric IOL,the angular orientation of the IOL in the eye is particularly important,as a toric IOL is intended for positioning after insertion at a specificangle, and, in currently available methods, that insertion angle must bemaintained, post-insertion, in order to provide a proper astigmaticcorrection. If the insertion angle is not correct and/or maintained, theastigmatism will not be fully corrected, and in fact the astigmaticcondition may worsen. The condition caused by this misalignment of theIOL is often referred to as residual cylinder, or remaining astigmatism.

Generally, astigmatism is an optical defect in which vision is blurreddue to the ocular inability to focus a point object into a sharplyfocused image on the retina. This may be due to an irregular, or toric,curvature of the cornea and/or lens. The refractive error of theastigmatic eye stems from a difference in degree of curvature, andtherefore in degree of refraction, of the different meridians of thecornea and/or the crystalline lens, which causes the eye to have twofocal points, one correspondent to each meridian. As used herein, ameridian includes one of two axes that subtend a curved surface, such asthe prime meridian on the earth, for example. Meridians may beorthogonal. By way of example, the meridians of the earth may be anyorthogonal line of longitude and any line of latitude that curve aboutthe surface of the earth.

For example, in an astigmatic eye, an image may be clearly focused onthe retina in the horizontal (sagittal) plane, but may be focused behindthe retina in the vertical (tangential) plane. In the case where theastigmatism results only from the cornea, the two astigmatism meridiansmay be the two axes of the cornea. If the astigmatism results from thecrystalline lens, the two astigmatism meridians may be the two axes ofthe crystalline lens. If the astigmatism results from a combination ofthe cornea and the crystalline lens, the two astigmatism meridians maybe the respective axes of the combined lenses of the cornea and thecrystalline lens.

Astigmatism arising from the cornea or crystalline lens, or thecombination of the two lenses, may be corrected by a toric lens, such asthe aforementioned toric IOL. A toric surface resembles a section of thesurface of a football, for which there are two regular radii ofcurvature, one smaller than another. These radii may be used to correctthe defocus in the two meridians of the astigmatic eye. Thus, blurredvision caused by astigmatism may be corrected by corrective lenses orlaser vision correction, such as glasses, hard contact lenses, contactlenses, and/or an IOL, that provide a compensating optic specificallyrotated around the optical axis. However, any misalignment of thecompensating optic, and/or improper selection of the corrective lens,may cause residual cylinder, or further astigmatism, and potentiallyinduce other aberrations. The aberrations may be exacerbated if, forexample multifocal and toric corrective lenses are required to correctthe initial condition, and the respective corrective lenses aremisaligned. Similarly, an initial condition may be exacerbated withmisalignment of aspheric surfaces used to correct spherical aberration,for example.

Thus, two specific issues arise from using a lens, such as an IOL, tocorrect astigmatism. First, toric ophthalmic lenses are sensitive tocylinder orientation misalignment relative to that to be corrected, suchas wherein the axis of the toric lens in the eye and the lens forcorrection are not accurately aligned. Second, the cylinder power of theeye or cornea may not sufficiently match the power of the toric IOL.This may be due to measurement errors, unintended changes of cylinderpower and/or axis during or after surgery, or because current toriclenses are offered only in a number of discrete cylinder increments.

A need therefore exists for a lens, such as an IOL, having decreasedsensitivity to alignment errors and also having decreased sensitivity toselection of the proper cylinder power, and for an optical system andmethod of providing and using the same.

SUMMARY OF THE INVENTION

The present invention is and includes apparatuses, systems, and methodsfor vision correction. An intraocular lens and a vision correctivesystem as provided in the present invention may include a toricintraocular element for correcting astigmatism and having a cylinderpower, and a depth of focus extender coupled to the toric intraocularelement, the depth of focus extender extending a depth of focus. Theextended depth of focus may reduce sensitivity of the toric intraocularelement to at least one of rotation and selected cylinder power.

A vision corrective optic and optical system as provided in the presentinvention may include a lens for correcting at least one aspect of aneye, the at least one aspect including at least one aberration, and adepth of focus extender coupled with the lens, the depth of focusextender extending a depth of focus of the lens. The depth of focusextender may increase at least one of alignment tolerance and matchingto the at least one aberration.

Also provided is a method for decreasing sensitivity of astigmaticcorrection to errors of cylinder power selection and lens rotationalalignment. The method may include receiving a measure of theastigmatism, receiving a selection of a toric lens matched to a negativeof the astigmatism, receiving a determination of a depth of focusextension for coupling with the selected toric lens, coupling thedetermined depth of focus extension and the selected toric lens, andinserting the coupled depth of focus extension and the selected toriclens in a line of sight.

Therefore, the present invention provides a lens, such as an IOL, havingdecreased sensitivity to alignment errors and to selection of propercylinder power, and a system and method of providing and using the same.

BRIEF DESCRIPTION OF THE FIGURES

Understanding of the present invention will be facilitated byconsideration of the following detailed description of the preferredembodiments of the present invention taken in conjunction with theaccompanying drawings, in which like numerals refer to like parts, andin which:

FIG. 1A is a schematic diagram of the optics of an eye;

FIG. 1B is a schematic diagram of the optics of an eye;

FIG. 2 is a depiction of an eye having astigmatism;

FIG. 3 is a depiction of an eye having corrected astigmatism;

FIG. 4 is a depiction of the anterior surface of a lens according to anaspect of the present invention;

FIG. 5 is a depiction of the posterior surface of a lens according to anaspect of the present invention;

FIG. 6 is a plot of image quality with respect to defocus for apseudophakic eye having no astigmatism;

FIG. 7 is a plot of image quality with respect to defocus for an eye inwhich the cornea has astigmatism;

FIG. 8 is a plot of image quality along the meridians of highest andlowest optical power, with respect to defocus of an astigmatic eyecorrection having 1 diopter of residual cylinder resultant fromalignment and cylinder power selection errors; and

FIG. 9 is a flow diagram illustrating a method for decreasing thesensitivity of astigmatic correction to errors of cylinder powerselection and rotational alignment.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

It is to be understood that the figures and descriptions of the presentinvention have been simplified to illustrate elements that are relevantfor a clear understanding of the present invention, while eliminating,for the purpose of clarity, many other elements found in typical lenses,lens systems and methods. Those of ordinary skill in the pertinent artsmay recognize that other elements and/or steps are desirable and/orrequired in implementing the present invention. However, because suchelements and steps are well known in the art, and because they do notfacilitate a better understanding of the present invention, a discussionof such elements and steps is not provided herein. The disclosure hereinis directed to all such variations and modifications to such elementsand methods known to those skilled in the pertinent arts.

Embodiments described herein provide a corrective lens, such as a toriclens, e.g. a toric IOL, toric contact lens, and/or toric inlay/onlay,having decreased sensitivity to alignment errors and to selection of theproper cylinder power in corrective optics. The described correctivelens, system and method provide an improved vision after implantation,and a decreased dependence on surgical skill. The present embodimentsfurther eliminate dependence of the extent of vision correction onvariations in patient healing after surgery, and, as such, greatlyimproves patient results, and patient comfort, following correctiveoptic implantation.

The disclosure also includes IOLs, contact lenses, spectacle lenses, andcorneal inlays, as well as corneal reshaping procedures and combinationsof the foregoing. Embodiments described herein also include a toric lensand an element extending the depth of focus, and may include each incombination with other refractive corrections, such as accommodatingophthalmic corrections, higher order aberration corrections, adjustablerefractive corrections, and multifocal refractive corrections, by way ofnon-limiting example.

According to an embodiment, an exemplary intraocular lens may include atoric intraocular element for correcting astigmatism, and a depth offocus extender coupled to the toric intraocular element, wherein thedepth of focus extender extending a depth of focus. As used herein“coupled” and “coupling” is defined to include separate elements and/orintegral surfaces, such as in a single lens, for example. The extendeddepth of focus may reduce sensitivity of the toric intraocular elementto at least one of rotation and the selected cylinder power of the toricelement.

Referring now to FIG. 1A, illustrated is a schematic diagram of theoptical system 10 of an eye. As may be seen in FIG. 1A, optical system10 may include a spectacle lens 20, a cornea 30, a natural lens 40 a,and a retina 50.

Referring now to FIG. 1B, illustrated is a schematic diagram of theoptical system 10 of an eye. As may be seen in FIG. 1B, optical system10 may include a spectacle lens 20, a cornea 30, an intraocular lens 40b, and a retina 50. Of note, intraocular lens 40 b in FIG. 1B hasreplaced natural lens 40 a of FIG. 1A in the illustrated embodiment. Inthe depictions of FIGS. 1A and 1B, cornea 30 may include an aberration,such as the spherical aberration of an average cataract patient as wouldbe understood by those possessing an ordinary skill in the pertinentarts. System 10 may also include a chromatic aberration of the humaneye, for example.

By changing the power of the lens 20 the defocus of the eye may bechanged. Therefore, the image quality on the retina as a function of theamount of ocular defocus may be determined. This function may bereferred to as a defocus curve. Image quality may be defined as acharacteristic of an image that measures the perceived image degradationfrom, typically, an ideal image. Image quality may be measured using apoint spread function, defocus curves, a modulation transfer function,or by analysis of the Zernike polynomial, for example, or by using othermathematical modeling or representation techniques. The point spreadfunction represents the intensity distribution of a point source asimaged through the optics of the eye. The strehl ratio is the maximum ofthe point spread function relative to the maximum of thediffraction-limited point spread function for a given pupil size, or thevolume of the modulation transfer function relative to the volume underthe diffraction-limited modulation transfer function for a given pupilsize. The strehl ratio, generally, may evidence a diffraction-limitedsystem if the ratio is greater than about 0.8, which represents theRayleigh criterion. For example, the image quality may be measured usingthe modulation transfer function and have any value in the range of0.01-1.0, or 1%-100%.

Emmetropia describes the state of vision wherein an object at infinityis in sharp focus, i.e., has high image quality in accordance with thedefocus curve, with the eye in a relaxed state. For an emmetropic eye,the eye has an optimum focus when spectacle lens 20 has a power of zerodiopters. For the exemplary emmetropic eye, a negative spectacle lenspower mimics the effect of looking at an object at a close distance, anda positive spectacle lens power mimics an object beyond infinitedistance.

FIG. 2 depicts an eye 100 having corneal astigmatism. FIG. 2 includes acornea 110 having a first curvature 120 on a first meridian, and asecond curvature 130 on a second meridian that is typically, althoughnot necessarily, perpendicular to the first meridian. Although FIG. 2depicts one meridian vertically and another meridian horizontally, theset of two perpendicular meridians may have any orientation, that is,may be rotated around the optical axis by an angle of “Θ”. The variationin curvature along the meridians causes two foci to be imaged by theeye, as discussed hereinabove. The distance between the foci representsthe astigmatism.

More specifically, a first focus 140 may be created by first curvature120 in cornea 110, and a second focus 150 may be created by secondcurvature 130 in cornea 110. Since the first focus 140 and the secondfocus 150 are not on the retina, as shown, the foci cannot be on theretina simultaneously using only spherical correction. Consequently,blurry vision results.

As discussed above, a lens may be used to correct for the astigmatismgenerated within the cornea correspondent to the unique foci of firstcurvature 120 and second curvature 130. Such a corrective lens mayinclude a toric lens that has a curvature difference between twoperpendicular meridians that matches or counteracts the cornea (firstcurvature 120 and second curvature 130), but that has an oppositelysigned (+/−) astigmatism. The opposite astigmatism reduces the totalastigmatism in the eye system 10. Just as astigmatism is a measure ofthe toricity of a lens, as described hereinabove, the negativeastigmatism is a measure of a lens having the opposite toricity.

For example, the astigmatism of the cornea may be denoted by an amount,−A, and an orientation “Θ”. A proper corrective lens may be selectedhaving an equal and opposite, that is, the negative, astigmatism ascompared to the cornea. This equal and opposite value may be denoted ashaving magnitude +A and orientation “Θ”.

If the aforementioned corrective lens were to be implanted in the eyewith the corrective magnitude and orientation precisely matching thecorneal astigmatic magnitude and orientation, then the cornealastigmatism would be at least substantially reduced, if not cancelled.However, there is typically a small angular error in the orientation ofthe lens that arises during implantation surgery, δ, so that theastigmatism of the lens is oriented at angle Θ+δ after implantation.This angular error is preferably kept as small as possible, but may notbe acceptably limited in practice due to measurement errors whenmeasuring corneal astigmatism, due to measurement errors when measuringcorneal astigmatism, misalignments during surgical implantation,postoperative changes in the cornea, postoperative IOL rotation, due toless than ideal surgical procedures, or due to other factors related tothe healing of the implanted eye. More specifically, while highlyaccurate surgical procedures may be able to achieve a δ no greater thanabout 5 degrees, less ideal surgical procedures or healing processes mayresult in angular errors larger than 5 degrees, and even an angularerror of 5 degrees may result in reduced visual acuity.

The astigmatism of the cornea (amount −A, orientation Θ), plus theastigmatism of the rotationally misaligned lens (amount +A, orientationΘ+δ), results in a residual astigmatism with magnitude 2 A sin δ,oriented at an angle (Θ+δ/2). Additional information regarding residualastigmatism may be found in T. Olsen, “Simple Method To Calculate TheSurgically Induced Refractive Change,” J Cataract Refract Surg 19(2),319-320 (1993), the entirety of which is incorporated by referenceherein as if set forth in its entirety. For example, an exemplary corneamay have 2 diopters of astigmatism, and a corrective lens may have 2diopters (of the opposite sign) of astigmatism. If the lens is implantedwith an angular error δ of precisely 5 degrees, then the residualastigmatism is (2) (2 diopters) (sin 5°), which is approximately 0.35diopters. For a tolerance of 10 degrees, the residual astigmatism is (2)(2 diopters) (sin 10°), which is approximately 0.7 diopters. A typicalthreshold for a visually noticeable astigmatism is 0.25 diopters,meaning that if the light reaching the retina has less than 0.25diopters of astigmatism, then the astigmatism does not significantlydegrade the vision of the eye. As such, the aforementioned angularerrors would produce a noticeable astigmatism, and thus may causepatient discomfort and/or sub-optimal post-surgical acuity.

FIG. 3 illustrates an eye 200 having corrected astigmatism. Eye 200 issimilar to the astigmatic eye 100 discussed above, with the addition ofIOL 210 into eye 100. Eye 100 has astigmatism, as evidenced by the focidepicted on opposite sides of the retina (140 and 150 in FIG. 2). IOL210 may be toric in design, having a first curvature 220 and a secondcurvature 230. In order to substantially completely correct, or at leastreduce, the astigmatism of eye 100, it is necessary that curvature 220match or counteract curvature 120, and that curvature 230 matches orcounteracts curvature 130, although partial correction may also beachieved by having a substantial curvature match or counteraction ineach axis. The corrected astigmatism is shown by focus 225. In additionto matching the curvatures, the correction lens may be aligned with thecornea. Misalignments in the angle of the IOL, either by placement or bypost surgical movement, may leave some residual astigmatism as discussedabove.

As used herein, the terms “extended focus” or “extended depth of focus”(EDOF) include a depth of focus of a test lens, optic, or opticalelement that exceeds the depth of focus of a reference optic. Thereference optic may have biconvex or biconcave surfaces, which may haveequal radii of curvature, and an optical power or focal length that maybe equal to an optical power or focal length of the test optic. Thedepth of focus for the test optic and the reference optic are determinedunder the same aperture conditions and under equivalent illuminationconditions.

In the case wherein the EDOF is attributable to a particular surfacefeature, structure, or mask associated with the test optic, thereference optic may be made of the same material, and have the samestructure, as the test optic, except without the particular feature,structure, or mask. For example, if a test optic is a refractive ordiffractive multifocal optic including a mask for extending the depth offocus of at least one of the foci formed by the test optic, then asuitable reference optic may be made of the same material(s) as the testoptic and have the same structure as the test optic (e.g., surfaceshapes/curvatures, thickness, aperture, echelette geometry, and thelike), but without the mask.

According to an embodiment, a corrective lens, such as IOL 210, mayinclude the toric lens described above in combination with one or moreelements designed to extend the depth of focus. The EDOF element mayproduce a depth of focus for each meridian. The depth of focus mayindicate a good focus for each meridian at a broader range of foci. Asused herein, good focus may be a focus that proves useful for vision,and that may be measured using a point spread function, defocus curves,a modulation transfer function (MTF), or by analysis of the Zernikepolynomial understood to those skilled in the pertinent arts, forexample.

The MTF may be used, for example, to predict or determine good focus,such as by simulation, and/or may be measured of the eye. MTF,therefore, relates to the contrast of alternating bright and dark barsin an image. For example, MTF is 1 when bright bars are completelybright and dark bars are completely dark. MTF is zero when bright barsand dark bars are equally gray. MTF may have a dependence on spatialfrequency that is inversely related to the width of the alternatingbright and dark bars in an image. Generally, an MTF may be measuredusing white light or may use green light, such as approximately 550 nmwavelength light, for example,

In determining or providing a depth of focus, an extended focus, or anEDOF, the determination may be based on a cut-off of the through-focusMTF at a particular spatial frequency. For example, the depth of focusmay be defined as the region in a through-focus MTF over which the MTF,at a spatial frequency of 50 line pairs per mm, exceeds a selectedcutoff value. Typical cutoff values may include 0.05, 0.10, 0.15, 0.17,0.20, 0.25, 0.3, 0.4 or higher. Other spatial frequencies may include 25line pairs per mm or 100 line pairs per mm, for example.

Further, the depth of focus may be based on a relative threshold, wherethe threshold is defined based on a peak value of the MTF. Relativethresholds may be 95%, 90%, 80%, 70%, 60%, 50%, 1/e, or 1/e² of a peakvalue of the MTF, full width at half maximum (FWHM) of the MTF, or anysuitable fraction of the peak value of MTF, or of any other metric. Forinstance, the depth of focus may be defined as the FWHM of the MTF at aparticular spatial frequency. As will be understood by a person havingordinary skill in the pertinent arts, FWHM is an expression of theextent of a function, and FWHM is indicated by the difference betweentwo extreme values of an independent variable at the point at which thedependent variable is equal to half of its maximum value.

In certain embodiments, the test optic with an EDOF discussedhereinabove may be evaluated in terms of an MTF, that is, based onoptical performance over a range of defocus conditions, as compared to areference optic, as is also discussed hereinabove. For example, a testoptic with an EDOF may have an MTF that is above a predeterminedthreshold value (e.g., 0.05, 0.10, 0.15, 0.17, 0.20, 0.25, or higher) ata particular frequency (e.g., 25, 50, or 100 line pairs per mm) over adefocus range that is greater than that of the corresponding referenceoptic. A threshold for acceptable vision may be an MTF at 50 lines permm greater than 0.2, or preferably greater than 0.4, for example. Thedefocus range may be expressed in terms of object space distances, imagespace distances, or diopter power. In certain embodiments, the testoptic with EDOF may be specified in terms of an increased depth of focusas compared to the corresponding reference optic, either in absoluteterms (e.g., an increased defocus range, compared to the referenceoptic, over which a predetermined MTF is maintained), or in relativeterms (e.g., a percent increase in defocus range, compared to areference optic, such as a 10%, 20%, 50%, 100%, 200%, or greaterincrease in defocus range compared to a reference optic).

Alternatively, other psychophysical metrics may be used to evaluate anEDOF element, such as, but not limited to, contrast sensitivity, visualacuity, and perceived blur. In addition, other metrics may be found inthe literature, such as those detailed in Marsack, J. D., Thibos, L. N.and Applegate, R. A., 2004, “Metrics of optical quality derived fromwave aberrations predict visual performance,” J Vis, 4 (4), 322-8;Villegas, E. A., Gonzalez, C., Bourdoncle, B., Bonnin, T. and Artal, P.,2002, “Correlation between optical and psychophysical parameters as afunction of defocus,” Optom Vis Sci, 79 (1), 60-7; van Meeteren, A.,“Calculations on the optical transfer function of the human eye forwhite light,” Optica Acta, 21 (5), 395-412 (1974). Each of theimmediately foregoing references is herein incorporated by reference inthe entirety.

As indicated by an MTF, for example, a retinal image may not suffer fromastigmatism from any residual uncorrected power as a result of corneaand toric IOL mismatch, if the uncorrected power is smaller than thedepth of focus provided by the EDOF element of the IOL. Similarly, theretinal image will not suffer from astigmatism when rotation of the IOLintroduces an astigmatism that is smaller than the depth of focusprovided by the EDOF element of the IOL. The EDOF element may preferablybe independent of rotation by having a rotational symmetry in order tominimize rotational effects during implantation or in-vivo, for example.Conversely, the EDOF element may be asymmetric, such as an oval ringshape, correspondent to, for example, asymmetric aspects of a subjecteye, such as a pupil size or shape, for example.

For example, the EDOF element may take the form of a low powerdiffractive element having a single diffractive structure. In such aconfiguration, the toric structure may be placed on the anterior surfaceof the IOL, and the diffractive structure may be placed on the posteriorsurface.

The EDOF element may also take the form of any element that increasesthe depth of focus. The EDOF element may be used in conjunction with abifocal lens or a trifocal lens. If the IOL is an EDOF element only, asdiscussed below with respect to FIG. 8, a bifocal lens may add to thepower of the cylinder.

A plurality of echellettes, including a central echellette, may serve asan EDOF element in accordance with certain disclosed embodiments, and asdescribed with respect to U.S. patent application Ser. No. 12/120,201,which is hereby incorporated by reference as if set forth herein in itsentirety. Additional EDOF elements are also illustratively provided inU.S. patent application Ser. No. 12/197,249, which is also incorporatedby reference as if set forth herein in its entirety.

A toric EDOF, as discussed further hereinbelow with respect to FIGS. 4-5and 7-8, may be combined with another diffractive element that may bedesigned to improve retinal image quality. The toric lens associatedwith such an EDOF element may be aspheric, and/or diffractive, and/orany type of toric design indicated to those skilled in the pertinentarts in light of the discussion herein. The EDOF element may include anyelement, item or method, or combinations thereof, for extending thedepth of focus. The proposed lens may be combined with a monofocal IOL,multifocal IOL, and/or accommodating IOL, by way of non-limiting exampleonly. More specifically, an EDOF element as described herein may beadded to a toric element, such as aspheric, multi-focal, oraccommodating IOL, for example, in order to provide the benefitsdescribed herein.

Referring now to FIG. 4, there is shown the anterior surface 310 of alens, such as IOL 210, according to an embodiment. Anterior surface 310may include a toric structure 330. As may be seen in FIG. 4, toricstructure 330 includes a first curvature 340 and a second curvature 350.For example, first curvature 340 may be along a first meridian andoriented vertically, and second curvature 350 may be along a secondmeridian and oriented horizontally.

With reference to FIG. 5, there is shown the posterior surface 410 of alens, such as IOL 210, according to an embodiment. Posterior surface 410includes an EDOF element 430. EDOF element 430 may include a low powerdiffractive element having a single diffractive structure 440. Singlediffractive structure 440 may include an annular structure that may bedesigned to provide the extended depth of focus. Examples of a singlediffraction structure include an annulus, zonal monofocal, low addrefractive bull's-eye and/or a ring structure having a periodicityand/or structure to manipulate focus. These and additional singlediffraction structures for use in embodiments may be modeled using knownoptical modeling techniques, including Zemax, Code V, and othersoftware, and the Liou-Brennan model for the human eye, in conjunctionwith the model eye of FIGS. 1A and B, to determine defocus curves, andto provide diffractive structures that operate to increase the depth offocus.

According to another embodiment, and by way of non-limiting exampleonly, toric structure 330 may have 4 diopters of cylinder. EDOF element430 may be a single diffractive structure that represents an add powerof 1.33 diopter, corresponding to about 1 diopter in the spectacleplane, for example.

Referring now to FIG. 6, there is shown a plot of image quality, asdefined hereinabove, with respect to defocus for a pseudophakic eyehaving no astigmatism. The plot of FIG. 6 is generated with respect tothe schematic eye of FIGS. 1A and B. As would be understood by thosepossessing an ordinary skill in the pertinent arts, a pseudophakic eyeis an eye that has an IOL implant present, and that has the crystallinelens of the eye removed. In the first case (diamond plot 610) of FIG. 6,the eye has a regular monofocal lens implanted, and, in the second case(square plot 620), the eye has a monofocal EDOF IOL implant having anextended depth of focus. The curves of FIG. 6 illustrate the trade-offbetween maximum image quality achievable for a prior art monofocal IOL,and the decreased, but broader range of acceptable image qualityavailable due to the increased depth of focus of the EDOF IOL plotted asan acceptable image quality over a range of defocus greater than 0.2 or0.1, for example.

As illustrated in FIG. 6, a monofocal IOL in accordance with the priorart may provide an image quality maximum of about 70, with a FWHM ofless than 1 diopter of defocus. An EDOF IOL may provide an image qualityof approximately 35, with a FWHM of approximately 2 diopters of defocus.Further, at an image quality maximum of approximately 15-20, forexample, the prior art IOL has a depth of focus of approximately 1diopter, while the EDOF IOL of the present invention has a depth offocus of approximately 2 diopters.

Thus, although the ideal image quality achieved with the prior art IOLmay be higher at maximum than the EDOF IOL, this peak image quality isseldom achieved using the prior art IOL because of postoperativeametropia (defocus), alignment problems, or due to healing, and/orbecause of cylinder power selection problems. Simply put, the plot ofFIG. 6 illustrates that the EDOF IOL of the present inventionconsistently provides a patient with a highly acceptable image qualityafter implantation, unaffected by the prior art need for idealcircumstances, due in part to the greatly increased range over which anacceptable image quality is provided by the EDOF IOL.

Referring now to FIG. 7, there is shown a plot of image quality withrespect to defocus for an eye in which the cornea has astigmatism, asdiscussed hereinabove. As explained previously, when the eye hasastigmatism, the astigmatism may be corrected by a toric lens. Thiscorrection may be ideal when the amount of cylinder power and thecylinder axis match that of the cornea in a pseudophakic eye to therebycancel any astigmatism, such a circumstance will produce the curves ofimage quality plotted against defocus shown in FIG. 6 for bothmeridians. If the cylinder power and axis are not matched, then the eyewill be left with a residual amount of cylinder, i.e. astigmatism.

FIG. 7 shows the situation in which the cornea has no or neglibleresidual cylinder. In one case (diamond plot 710), the eye has anessentially perfectly matched prior art toric IOL implanted, and, in theother case (square plot 720), the eye has a toric EDOF IOL implantedhaving an extended depth of focus. The plot demonstrates the tradeoffbetween maximum image quality achieved over a narrow range for the priorart toric IOL, and the improved image quality over a much broader rangeprovided by the toric EDOF IOL.

Referring now to FIG. 8, there is shown a plot of image quality withrespect to defocus of a correction in which there is about 1 diopter ofresidual cylinder that may result from either an alignment error, amismatch between cylinder power of the cornea and the IOL, or both.Because an eye having a residual amount of cylinder, or astigmatism, hasa different image quality in each meridian, the defocus curves alsodiffer for each meridian. That is, the defocus curve may reflect thatthe difference between the minimum power and the maximum power is equalto the residual cylinder. The plot of FIG. 8 shows two defocus curvesfor each situation, one in which the meridian has a maximum power, andone in which the meridian has a minimum power.

FIG. 8 further illustrates the presence of residual cylinder. In onecase, with first meridian (diamond plot 810) and second meridian(triangle plot 815), the eye has a prior art toric IOL implanted, and,in the other case, with first meridian (square plot 820) and secondmeridian (circle plot 825), the eye has a toric EDOF IOL implanted. Inboth cases, the defocus curves are shown for the meridians of highestand lowest optical power. FIG. 8 demonstrates that, for both cases, theimage quality at each meridian may be about the same at approximatelyzero defocus. This may occur because the respective maximum opticalpower and respective minimum optical power of each defocus curve isabout equally displaced from zero defocus. FIG. 8 also demonstrates thatthe image quality may be higher for the implanted lens with the EDOFimplanted than for an implantation of the prior art toric IOL alone.

More specifically and by way of specific example, for an eye having aprior art toric IOL without an EDOF element, with about 1 diopter ofresidual cylinder, the best focus for an image may be at a zero defocus,whereat an image quality of about 20 may be achieved. In contrast, foran eye having a toric IOL including an EDOF element, and with about 1diopter of residual cylinder, the best focus for the image may be atzero defocus, whereat an image quality of about 30 may be achieved.Thus, the toric IOL with the EDOF may achieve an increased image qualitywhen surgical, selection, implantation, or environmental errors occur,such as an error in the form of 1 diopter of residual cylinder, ascompared to the prior art toric IOL. More specifically, by use of anEDOF element that broadens and flattens the curve for a range ofacceptable image quality over a range of defocus, an EDOF IOL mayimprove the image quality equal to or greater than about 50%.

For example, it has been experimentally assessed that a lens, such as anIOL, incorporating an EDOF element may optimally produce a retinal imagewith reduced residual astigmatism, and thus with increased imagequality, when the eye astigmatism is between about 0.5 and 10 diopter,and more specifically between about 0.5 and 6 diopters, and yet morespecifically between about 0.5 to 5 diopters. This assumes noappreciable measurement errors for astigmatism, essentially perfectcontrol over surgically induced astigmatism, and essentially perfectalignment of the lens. As mentioned previously, lens alignment errors(such as rotation) may result in an increase of residual astigmatism,and a change of the cylinder axis. Nonetheless, within these limits, theproposed lens, such as an IOL, may produce a retinal image withoutappreciable astigmatism, as long as the residual astigmatism is smallerthan the depth of focus, such as about 1 or 2 diopters, of the EDOFelement.

According to an embodiment, when the corrected astigmatism is small,such as in the range of about 0 to 3 diopters, or more specifically inthe range of about 0 to 2 diopters, or yet more specifically in therange of about 0 to 1 diopters, the proposed lens may be used withessentially zero cylinder, that is, may be used with respect to only theEDOF aspects described herein. This is a significant advantage, in partbecause the axis of small amounts of astigmatism are difficult tomeasure, and therefore are not only difficult to correct, but are alsoeasily worsened. Use of embodiments with zero cylinder may provide foran avoidance of any worsening of a minor, immeasurable prior condition.Further, the proposed lens using only the EDOF element may workindependent of the axis, thereby further alleviating the alignmentissues in the prior art.

Referring now to FIG. 9, there is shown a method 900 for decreasing thesensitivity of astigmatic correction to errors of cylinder powerselection and rotational alignment. Method 900 includes receiving(and/or generating) a measured astigmatism of the eye 910. Method 900may further include receiving (and/or providing) a selection of toriclens 920 that most closely matches or counteracts the measuredastigmatism. An EDOF element determination may be received (and/orprovided) 930 for use in increasing the depth of focus of the selectedlens. The determined EDOF element may be received (and/or provided) 940in combination with the selected toric lens. The combined toric lens andthe EDOF element may be used to correct 950 the measured astigmatism,providing a decreased sensitivity to astigmatic correction errors ofcylinder power selection and rotational alignment.

The determination of the EDOF element, such as step 930, may beperformed based upon historic data of residual astigmatism. For example,the historic residual astigmatism as obtained with a prior art toric IOLmay be used as the defocus range for the EDOF element. For furtherenhancement, the historic data may be broken down by surgical procedure,by cylinder power, by patient group, by surgeon, and by combinations ofthese sources, for example. By way of non-limiting example, history mayshow that, for a desired tolerance with a 5-10 degree misalignment onaverage, and with 1-2 diopters of residual astigmatism, an EDOF elementwith 1-2 diopters of EDOF is optional. Alternatively, the EDOF elementmay be chosen equal or proportional to 2 A sin 2δ, in which A is thecorneal astigmatism, and δ is the maximum predicted misalignment.

It should be appreciated in light of the disclosure herein that themethod of the present invention may also be applied as a laserrefractive procedure, and/or may be applied on an adjustable ophthalmiclens. It should be further appreciated that the method may be applied asa custom lens design, and or as a combined procedure, such as bycombining a diffractive EDOF element IOL with a toric laser refractiveprocedure, for example.

In an illustrative embodiment, and as discussed herein at least withrespect to FIGS. 2-5 and 8-9, the cornea may have astigmatism. Thehorizontal meridian may be the low power meridian, and may have acorneal power of 40 diopters. The vertical meridian may be the highpower meridian, and may have a corneal power of 43 diopters. As such,the corneal astigmatism may be 3 diopters, with an orientation of zerodegrees. A toric IOL that matches or counteracts the cornealastigmatism, such as with low meridian along the vertical and highmeridian along the horizontal, may have astigmatism of approximately 4diopters, as a result of the fact that the IOL is located within theeye, as opposed to a contact lens, for example, which may be chosen tocorrect the astigmatism of this example by precisely matching theastigmatism of 3 diopters.

In this example, the clinical history of the surgeon, using aconventional toric IOL, may indicate an average residual astigmatism ofabout 0.3 diopters. This residual astigmatism may result from thecombined errors of cylinder mismatch, IOL rotation, surgically inducedastigmatism, and the like. An EDOF element may thus be selected having adepth of focus of at least 0.3 diopters. For example, the EDOF elementmay produce a depth of focus of 0.75 diopters in the corneal plane, andthus about 1 diopter in the IOL plane.

By way of additional example, kits or quasi-custom designs may beutilized. For example, knowing the trade-offs between misalignmenttolerance and MTF limits, a surgeon may desire up to 10 degrees ofmisalignment tolerance and a MTF greater than 0.2, and may consequentlyselect a Type 1 lens and EDOF element. If the surgeon desires 5 degreesof misalignment tolerance and an MTF greater than 0.3, a selection of aType 2 lens and EDOF element may be indicated.

An EDOF element may be achieved by using any number of EDOF elements.For example, the provided EDOF element may be a low power diffractivebifocal structure on the posterior surface of the IOL. The diffractivebifocal structure may have multiple rings, or may be selected with acentral diffractive echellette having a diameter of 2 mm, for example.The resulting lens may have a toric anterior surface, with astigmatismof 4 diopters, and on the posterior surface may have a diffractiveelement producing a depth of focus of 1 diopter. Such an IOL maytolerate a mismatch between the cornea and IOL of +/−0.5 diopter, and atotal range of 1 diopter, in the IOL plane. The lens may tolerate arotation of about 5 degrees, and thus rotation of greater than 5 degreesmay produce a residual astigmatism that is approximately 0.5 diopterslower than a similar configuration using a conventional toric IOL.

Although the invention has been described and pictured in an exemplaryform with a certain degree of particularity, it should be understoodthat the present disclosure of the exemplary form has been made by wayof example, and that numerous changes in the details of construction andcombination and arrangement of parts and steps may be made withoutdeparting from the spirit and scope of the invention as set forth in theclaims hereinafter.

The invention claimed is:
 1. An intraocular lens, comprising: an opticcomprising a first surface having a first shape and an opposing secondsurface having a second shape, the first and second shapes providing arefractive power; a diffractive pattern imposed on at least one of thefirst shape and the second shape; the first and second surfacesproviding a base power and an add power; wherein, when the optic isplaced in an intraocular lens plane of a physical eye model including amodel cornea, the modulation transfer function of the eye model exceedsabout 0.17, at a spatial frequency of about 50 line pairs permillimeter, over a range of at least about 1.7 Diopters.
 2. Anintraocular lens, comprising: a first surface having a first shape andan opposing second surface having a second shape, the first and secondshapes providing a refractive power; a diffractive pattern imposed onthe first shape or the second shape; the first and second surfacesproviding a base power and an add power; the intraocular lens having adepth of focus, when illuminated by a light source, that is at leastabout 30% greater than that of an intraocular reference lens without thediffractive pattern, the intraocular reference lens having a refractivepower that is equal to the base power of the intraocular lens.
 3. Theintraocular lens of claim 2, wherein the light source is a polychromaticlight source.
 4. The intraocular lens of claim 2, wherein the lightsource is at a predetermined wavelength and the intraocular lens has adepth of focus, when illuminated at the predetermined wavelength, thatis at least about 50% greater than that of the intraocular referencelens.
 5. The intraocular lens of claim 2, wherein, at a spatialfrequency of about 50 line pairs per millimeter, the modulation transferfunction of the lens exceeds 0.17 over a depth of focus that is greaterthan the depth of focus for the reference intraocular lens by at leastabout 0.5 Diopters.
 6. The intraocular lens of claim 2, wherein theintraocular lens is optically described by a model lens, such that whenthe model lens is included in an intraocular lens plane of an eye modelincluding a model cornea, the modulation transfer function of the eyemodel exceeds about 0.17, at a spatial frequency of about 50 line pairsper millimeter, over a range of at least about 1.7 Diopters.